a unified digital space that monitors all facility manufacturing operations and supply chain logistics with real-time data acquisition and notifications

electronic batch records that trace every manufacturing step with automation to increase productivity, reinforce GMP compliance, and improve the security of patients’ samples through increased traceability

eSOPs designed for specific processes to manage deviations, promote adherence to protocol, and provide guidance to ensure sensitive patient cells are handled appropriately

Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare, said: “The full potential of cell and gene therapies cannot be realized without comprehensive digital solutions that optimize manufacturing processes and can scale from process development to commercialization. Chronicle automation software was designed to meet the digital needs of academic researchers and large biotechnology companies and will help ensure increased patient access to life-saving therapies.”

Olin Thomas, Manager of Stem Cell Processing at Vanderbilt University Medical Center, said: “Automation software provides our lab with a flexible digital solution that streamlines our workflow. Because the software was designed to fit our specific requirements, we have been able to incorporate the platform into our existing software and hardware framework for a seamless integration.”

Built by cell therapy platform solution engineers, Chronicle software integrates with the full range of GE instruments as well as many third-party instruments. It has been independently audited against GAMP5, 21 CFR Part 11, and EU Annex 11 and is available immediately.

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